Medical device identification system

Abstract

Instrumentation and methods of use are provided for a medical device identification system. The application describes embodiments of a system including a medical device, and an identification tag having an RFID chip and an electrical circuit. The system defines a first configuration in which a first attachment region of the electrical circuit is in electrical communication with a second attachment region of the electrical circuit, and a second configuration in which the first attachment region is electrically isolated from the second attachment region. When the system is in the first configuration the RFID chip is in a first state, and when the system is in the second configuration the RFID chip is in a second state different than the first state.

What is claimed: 
     
       1. A medical device identification system comprising:
 a medical device; and 
 an identification tag coupled to the medical device, the identification tag including an RFID chip and an electrical circuit, the electrical circuit including at least one electrically conductive wire defining a first attachment region attached to the RFID chip at a first RFID location, and the at least one electrically conductive wire further defining a second attachment region, a third attachment region, and a fourth attachment region, the second attachment region attached to the RFID chip at a second RFID location that is spaced from the first RFID location, the electrical circuit defining a path between the first attachment region and the second attachment region, the third attachment region positioned on the path between the first attachment region and the second attachment region, and the fourth attachment region positioned on the path between the third attachment region and the second attachment region; 
 wherein 1) the system defines a first configuration in which the first attachment region is in electrical communication with the second attachment region along the electrical circuit, and a second configuration in which the first attachment region is electrically isolated from the second attachment region along the electrical circuit, 2) the RFID chip is in a first state when the system is in the first configuration, and the RFID chip is in a second state different than the first state when the system is in the second configuration, and 3) when the system is in the first configuration the third attachment region and the fourth attachment region are each attached to the medical device, and when the system is in the second configuration the third attachment region and the fourth attachment region are separated by a gap such that the third and fourth attachment regions are electrically isolated from one another. 
 
     
     
       2. The system of  claim 1 , wherein the medical device includes at least one of: 1) an implant configured to be implanted in a human body; and 2) an instrument configured for use in a medical procedure. 
     
     
       3. The system  claim 1 , wherein the electrical circuit is coupled to the medical device such that decoupling of the identification tag from the medical device causes a break in the electrical circuit at a location between the first attachment region and the second attachment region such that the electrical circuit is open. 
     
     
       4. The system of  claim 1 , wherein the RFID chip is an active chip that emits a radio frequency signal when the electrical circuit is closed, the identification tag includes an antenna configured to transmit the radio-frequency signal, the radio-frequency signal includes information that indicates whether the RFID chip is in the first state or the second state, and the electrically conductive wire defines at least a portion of the antenna. 
     
     
       5. The system of  claim 1 , wherein the RFID chip is an active chip that emits a radio frequency signal when the electrical circuit is open, the identification tag includes an antenna configured to transmit the radio-frequency signal, the radio-frequency signal includes information that indicates whether the RFID chip is in the first state or the second state, and the electrically conductive wire defines at least a portion of the antenna. 
     
     
       6. The system of  claim 5 , wherein the medical device defines a portion of the electrical circuit. 
     
     
       7. A method of assembling a medical device identification system, the method comprising the steps of:
 coupling an identification tag to a medical device such that 1) a first attachment region of an electrical circuit of the identification tag that is attached to an RFID chip of the identification tag at a first RFID location on the RFID chip is in electrical communication with a second attachment region of the electrical circuit of the identification tag that is attached to the RFID chip at a second RFID location on the RFID chip that is spaced from the first location and 2) the system is in a first configuration in which the RFID chip is in a first state; 
 the coupling step including the step of inserting the medical device into a recess of a substrate such that the medical device defines a portion of the electrical circuit; 
 the inserting step includes the step of moving the medical device into contact with both 1) a third attachment region of the electrical circuit that is positioned between the first attachment region and the second attachment region and 2) a fourth attachment region of the electrical circuit that is positioned between the third attachment region and the second attachment region; and 
 placing the coupled medical device and identification tag into an interior of an enclosure, 
 wherein the system defines a second configuration in which 1) the first attachment region is electrically isolated from the second attachment region along the electrical circuit and 2) the RFID chip is in a second state different than the first state. 
 
     
     
       8. The method of  claim 7 , wherein the medical device includes an implant configured to be inserted into a human body, and the interior of the enclosure is a sterile interior. 
     
     
       9. The method of  claim 8 , wherein the moving step includes at least one of: 1) rotating the medical device about an axis with respect to the substrate, and 2) translating the medical device along an axis with respect to the substrate. 
     
     
       10. A method of implanting an implant, the method comprising the steps of:
 selecting an implant for implantation into a patient, wherein the implant is coupled to an identification tag that includes an RFID chip and an electrical circuit, the electrical circuit including at least one electrically conductive wire, the at least one electrically conductive wire defining a first attachment region attached to the RFID chip at a first RFID location, and the at least one electrically conductive wire defining a second attachment region attached to the RFID chip at a second RFID location spaced from the first RFID location, wherein the first attachment region is in electrical communication with the second attachment region along the electrical circuit, and the RFID chip is in a first state; 
 decoupling the identification tag from the implant so as to cause a break in the electrical circuit, thereby electrically isolating the first attachment region from the second attachment region along the circuit; 
 the decoupling step including the step of removing the implant from a recess of a substrate of the system; 
 the removing step includes moving the implant out of contact with both 1) a third attachment region of the electrical circuit that is positioned between the first attachment region and the second attachment region and 2) a fourth attachment region of the electrical circuit that is positioned between the third attachment region and the second attachment region; 
 in response to the decoupling step, causing the RFID chip to define a second state that is different than the first state; 
 implanting the decoupled implant into the patient; and 
 sensing the second state of the RFID chip. 
 
     
     
       11. The method of  claim 10 , wherein the moving step includes rotating the implant about an axis with respect to the substrate. 
     
     
       12. The method of  claim 10 , wherein the moving step includes translating the implant along an axis with respect to the substrate. 
     
     
       13. The method of  claim 10 , wherein the decoupling step includes removing a portion of the implant from a first area having an outer perimeter defined by the at least one electrically conductive wire. 
     
     
       14. The method of  claim 10 , further comprising the steps of:
 transmitting the second state of the RFID chip; 
 storing the second state of the RFID chip; and 
 associating the second state of the RFID chip with the patient, wherein the associating step includes recording the state of the RFID chip in a file associated with the patient.